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FDA Approval Increases Eligibility for Cystic Fibrosis Medication Trikafta
According to Vertex Pharmaceuticals, approximately 300 additional people with CF are now eligible to receive treatment.
FDA approves drugs from Vertex, Novo, Bristol Myers to wrap 2024
The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end ...
FiercePharma10d
Vertex snags FDA nod for once-daily cystic fibrosis triplet Alyftrek as switch from Trikafta kicks off
As Vertex Pharmaceuticals reels from a painful trial readout for its pain candidate suzetrigine, the Boston biotech has ...
Cystic Fibrosis Foundation12d
FDA Approves Trikafta for 94 Additional Rare CFTR Mutations
The U.S. Food and Drug Administration (FDA) today approved the expansion of Trikafta (elexacaftor/tezacaftor/ivacaftor) to ...
Vertex wins approval for new once-daily CF drug
Vertex Pharmaceuticals Inc. notched two FDA victories late Friday for its cystic fibrosis medicines, increasing the number of ...
BioSpace10d
Vertex Wins FDA Approval for New Cystic Fibrosis Option but Stock Still Down
The new combination, dubbed Alyftrek, is designed to improve on the Trikafta, a product that generated sales of $8.9 billion ...
Business Wire13d
Vertex Announces U.S. FDA Approval for TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Include Additional Non-F508del TRIKAFTA-Responsive Variants
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of TRIKAFTA ® (elexacaftor ...
Monthly Prescribing Reference6d
FDA Approval Increases Eligibility for Cystic Fibrosis Medication Trikafta
Participants were randomly assigned to receive Trikafta or placebo based on age and weight: Aged 6 to <12 years and less than 30kg: morning dose of elexacaftor 100mg/tezacaftor 50mg/ivacaftor 75mg ...
Cystic Fibrosis Foundation12d
FDA Approves New, Once-a-Day CFTR Modulator for People With CF
A new CFTR modulator treatment called Alyftrek has been approved for people with CF ages 6 and older who have CFTR mutations ...
Vertex' Trikafta Gets Expanded FDA Approval For Cystic Fibrosis Treatment
Vertex Pharmaceuticals (VRTX) said Friday the U.S. Food and Drug Administration expanded its approval of a cystic fibrosis treatment, ...
Vertex announces FDA exands approval for Trikafta
Vertex Pharmaceuticals (VRTX) announced the U.S. Food and Drug Administration has approved the expanded use of Trikafta for the treatment of ...
Zacks.com on MSN10d
Vertex Secures FDA Approval for New Cystic Fibrosis Drug Alyftrek
The FDA's nod is based on late-stage data, which show that treatment with VRTX's Alyftrek enhances patient benefit compared ...